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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-ECR IOL PAS


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General
Study Status Progress Adequate
Application Number P980040 S058/ PAS001
Date Current Protocol Accepted 03/03/2017
Study Name OSB Lead-ECR IOL PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this post-approval study is to evaluate the rates of severe visual distortions for the TECNIS Toric IOLs

with Extended Cylinder Range of approximately 3.00 D to 4.75 D of cylinder correction at the corneal plane (Models

ZCT450, ZCT525 and ZCT600) in clinical practice and to ensure the continued safety of the approved devices.

Study Design: Prospective, multicenter, bilateral, non-randomized, open-label clinical new enrollment study.

Study Population Description Bilateral cataracts with corneal astigmatism of approximately 2.00 D to 4.75 D (with 3.00 D to 4.75 D in at least one eye) based on the combination of preoperative keratometirc cylinder and the expected effect of surgicallyinduced astigmatism (SIA).There is no control group.
Sample Size Up to 120 subjects will be enrolled to achieve bilateral implantation in approximately 80 subjects; a minimum of 15 subjects will be implanted with a TECNIS Toric ZCT600 in at least one eye, and the remaining subjects will be implanted with either a TECNIS Toric ZCT450, ZCT525 or ZCT600 in at least one eye. With 80 subjects and a severe visual distortion rate of 0.025, this study has 86% probability of achieving a half-width of 0.05 for a 95% confidence interval for the rate of severe visual distortions.

Subjects will be enrolled at up to 20 sites in the United States. Each site should implant a minimum of 6 subjects, and no site may enroll more than 20% of the enrollment total.

Data Collection Study Endpoints

Primary Endpoint

The primary endpoint is the rate of severe visual distortions based on data collected from a self-administered Patient

Reported Visual Distortion Questionnaire (PRVDQ).

The rate of severe visual distortions is defined as the percentage of subjects who report a severe visual distortion under overall circumstances at 6 months postoperative for any of the following 5 visual distortion items of interest:

lines that slant, tilt, split or separate

flat surfaces appearing curved

objects appearing further away or closer than they actually are objects appearing to have a different size or shape

physical discomfort related to vision

Distortions will be assessed using the overall circumstance reply at the 6-month visit. The frequency and proportion of subjects reporting one or more of these items as severe will be used to determine the rate of severe visual distortions.

Secondary Endpoints

Ratings of individual items included in the visual distortion questionnaire (PRVDQ)

Mean percent reduction in absolute cylinder

Mean refractive cylinder, mean refractive cylinder compared to intended, mean spherical equivalent and mean spherical equivalent compared to intended

Percent of eyes with absolute cylinder within 0.50 D and within 1.00 D of intended

Percent of eyes with spherical equivalent within 0.50 D and within 1.00 D of intended

Uncorrected distance visual acuity (monocular and binocular)

Best corrected distance visual acuity (monocular and binocular)

Rates of medical and/or lens findings

Rates of IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment

Mean difference between IOL axis marker location and postoperative steep keratometry meridian

Rates of other adverse events

Follow-up Visits and Length of Follow-up 6 months total follow up


OSB Lead-ECR IOL PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/29/2016 01/29/2016 On Time
one year report 07/30/2016 07/28/2016 On Time
18 month report 01/28/2017 01/23/2017 On Time
two year report 07/30/2017 09/07/2017 Overdue/Received
three year report 07/30/2018    
four year report 07/30/2019    
five year report 07/29/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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